Systems and methods for implantable leadless gastrointestinal tissue stimulation

Abstract

Systems and methods are disclosed to stimulate gastrointestinal tissue to treat medical conditions such as eating disorders, gastroparesis, and gastric reflux. The invention uses electrical stimulation of the nerve, where vibrational energy from a source is received by an implanted device and converted to electrical energy and the converted electrical energy is used by implanted electrodes to stimulate the pre-determined gastrointestinal tissue site. The vibrational energy is generated by a controller-transmitter, which could be implanted or located externally. The vibrational energy is received by a receiver-stimulator, which could be located in the various regions on or around the gastrointestinal tissue that needs to be stimulated. The implantable receiver-stimulator stimulates different gastrointestinal tissue to provide the desired therapeutic benefit.

1. A method for stimulating gastrointestinal tissue comprising:
 implanting in a body of a patient a controller-transmitter at an implantation site to generate acoustic energy, wherein the controller-transmitter comprises acoustic transducers disposed in a housing and one or more physiological sensors disposed on an external surface of the housing, and wherein the one or more physiological sensors are configured to detect one or more physiological parameters; 
 implanting a receiver-stimulator remotely from the controller-transmitter in gastrointestinal tissue of the patient at a gastrointestinal tissue stimulation site, wherein the receiver-stimulator comprises one or more stimulation electrodes such that the stimulation electrodes lie in electrical communication with the gastrointestinal tissue stimulation site; 
 sensing one or more physiological parameters directly from the body using the one or more physiological sensors; 
 generating acoustic energy at the controller-transmitter implantation site using the transducers in the controller-transmitter; 
 receiving the acoustic energy at the gastrointestinal tissue stimulation site using the receiver-stimulator; 
 converting the received acoustic energy into an electrical gastrointestinal tissue stimulation energy output using the receiver-stimulator, wherein the stimulation energy output has at least one of pulse amplitude, pulse duration, duty cycle, and timing based on energy and signal information included in the generated acoustic energy; 
 delivering the electrical gastrointestinal tissue stimulation energy output to the gastrointestinal tissue stimulation site using the one or more stimulation electrodes; 
 sensing the electrical gastrointestinal tissue stimulation energy output, wherein the physiological sensors are adapted to sense the electrical gastrointestinal tissue stimulation energy output; 
 adjusting the acoustic energy transmission from the controller-transmitter to compensate for changes in the electrical gastrointestinal tissue stimulation energy output of the receiver-stimulator; and 
 using an external programmer to program one or more settings of the controller-transmitter. 
 
     
     
       2. A method as in  claim 1  wherein the gastrointestinal tissue stimulation further comprises:
 operating the controller-transmitter such that electrical gastrointestinal tissue stimulation energy output is generated by the receiver-stimulator at the predetermined gastrointestinal tissue stimulation site; 
 wherein the predetermined gastrointestinal tissue stimulation site is chosen to treat one or more medical conditions chosen from the list comprising eating disorders, 
 gastroparesis, and gastric reflux. 
 
     
     
       3. A method of  claim 1 , wherein receiving comprises receiving the energy output at two or more gastrointestinal tissue stimulation sites. 
     
     
       4. A method of  claim 3 , wherein the signal information stimulates different sites sequentially. 
     
     
       5. A method of  claim 3 , wherein the signal information stimulates different sites simultaneously. 
     
     
       6. A method as in  claim 1 , wherein the housing is a hermetically sealed housing. 
     
     
       7. A method as in  claim 6 , wherein the one or more physiological sensors have a portion within the housing and a portion external to the housing. 
     
     
       8. A method as in  claim 7 , wherein the one or more physiological sensors are directly connected to a signal processing circuitry of the controller-transmitter. 
     
     
       9. A method as in  claim 1 , wherein the external programmer transmits a radiofrequency signal and the controller-transmitter comprises circuitry for receiving the radiofrequency signal. 
     
     
       10. A method as in  claim 1 , wherein the receiver-stimulator consists essentially of an ultrasound transducer which generates a stimulation signal in response to the acoustic energy transmitted by the controller-transmitter, circuitry which rectifies the stimulation signal, and at least one electrode which delivers the rectified signal as the electrical gastrointestinal tissue stimulation energy output to gastrointestinal tissue.